CompletedNot Applicable

Lactoferrin-enriched Dairy Product in Gestational Diabetes

Italy50 participantsStarted 2023-03-01

Plain-language summary

This pilot double-blind, randomized controlled trial with two parallel arms, was performed to evaluate the change in serum ferritin concentration following consumption of lactoferrin enriched yogurt versus the non-enriched control yogurt in women with GDM.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of GDM confirmed by 75g glucose oral glucose tolerance test (OGTT). * Caucasian ethnicity, gestational age between 24 and 30 weeks. * Age \>18 and \<50 years. * Body Mass Index (BMI) between 22.5 and 35 kg/m². * Ability to provide informed consent to participate in the study. Exclusion Criteria: * Type 1 diabetes mellitus. * Allergies to milk proteins or lactose intolerance. * Known anemia. * Twin pregnancy. * Pre-existing iron supplementation exceeding 30 mg/day. * Insulin therapy at the time of enrollment. * Any condition or disease requiring specific dietary treatments. * Concurrent physical or mental conditions requiring pharmacological therapy * Autoimmune disorders.

What they're measuring

Change in serum ferritin levels after consumption of lactoferrin-enriched yogurt compared to the non-enriched control yogurt.

Timeframe: 8 weeks - The change in serum ferritin concentration was assessed from baseline to the end of the intervention period.

Trial details

NCT IDNCT07287384

SponsorUniversity of Turin, Italy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Gestational Diabetes Mellitus (GDM) trials